Last updated: March 8, 2023
Sponsor: Beijing Friendship Hospital
Overall Status: Active - Not Recruiting
Phase
3
Condition
White Cell Disorders
Lymphoma
Bone Marrow Disorder
Treatment
N/AClinical Study ID
NCT05775705
BFH20220920001
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.
- EBV-DNA in peripheral blood > 1000 copies/ml or EBER detected in tissue specimens.
- Age 18~65,gender is not limited.
- Estimated survival time ≥ 1 month.
- Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestivetract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >250.
- Signed informed consent.
Exclusion
Exclusion Criteria:
- Heart function above grade II (NYHA).
- Severe myocardial injury:TNT、TNI、CK-MB > 3 ULN.
- Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicinabove 800mg/m2 or the patients treated with anthracycline induced cardiovasculardisease.
- Pregnancy or lactating Women.
- Allergic to pegylated liposomal doxorubicin,etoposide,or PD-1 antibody.
- Thyroid dysfunction.
- HIV antibody positivity.
- Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable),acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibodypositivity, HCV RNA negative acceptable).
- Participate in other clinical research at the same time.
- The researchers considered that patients are not suitable for the study.
Study Design
Total Participants: 25
Study Start date:
August 01, 2023
Estimated Completion Date:
October 01, 2026
Study Description
Connect with a study center
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing 100050
ChinaSite Not Available
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